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FDA 510(k)

TotalC-Ram

K-Number: K162960 · 2017-03-14

ApplicantItena Clinical
Decision Date2017-03-14
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TotalC-Ram is a medical device manufactured by Itena Clinical. It received FDA 510(k) clearance on 2017-03-14 under approval number K162960. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TotalC-Ram?

TotalC-Ram is a medical device that received FDA 510(k) clearance on 2017-03-14. It is manufactured by Itena Clinical. The 510(k) number is K162960.

When was TotalC-Ram approved by the FDA?

TotalC-Ram received FDA 510(k) clearance on 2017-03-14, under approval number K162960.

What company makes TotalC-Ram?

TotalC-Ram is manufactured by Itena Clinical.

What is the FDA product code for TotalC-Ram?

The FDA product code for TotalC-Ram is EMA.

Other Devices by Itena Clinical

K170207Obturys

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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